Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH

NCT00597480 Phase 4 TERMINATED

Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 4
Status	TERMINATED
Enrolment	10
Start date	2008-01
Completion	2012-01

Conditions

• Small for Gestational Age

Interventions

• rhGH (Norditropine SimpleXx®)
• rhGH norditropine simple Xx

Primary outcomes

• Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA — every three months during twenty seven months

Countries

France